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Investigational research of an automatic control of vasoactive drug and infusion volume

Investigational research of an automatic control of vasoactive drug and infusion volume to avoid abnormal hypotension

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052230120
Enrollment
100
Registered
2023-10-27
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with ASA physical status of 1 and 2, scheduled for surgery under total intravenous anesthes

Interventions

Sponsors

Matsuki Yuka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female patients over 20 years old at the time of informed consent 2. Patients with ASA physical status of 1 and 2 who are scheduled for surgery under general anesthesia 3. Patients who understand the contents of this study and are willing to provide written informed consent for participation in this study

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitive to propofol, remifentanil, rocuronium or sugammadex 2. Patients who cannot connected BIS Sensor for placement on the forehead 3. Patients who cannot received rocuronium after first single dose 4. Patients who cannot measured non-invasive sphygmomanometer 5. Patients undergoing surgery with hypothermia 6. Patients undergoing cardiovascular surgery 7. Patients with supraventricular rhythm irregularities such as atrial fibrillation, atrial flutter, or sinus arrhythmia 8. Patients with expected blood loss of 1000 mL or more 9. Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant 10. Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant

Design outcomes

Primary

MeasureTime frame
Percentage of time during the evaluation period when mean blood pressure was 65 mmHg or higher and esSVI was maintained above threshold

Secondary

MeasureTime frame
1. Percentage of time during the evaluation period when the mean blood pressure was less than 65 mmHg 2. Percentage of time during the evaluation period when esSVI was below threshold 3. Doses of infusion fluids used during the evaluation period 4. Dose of phenylephrine used during the evaluation period 5. Urine volume 6. oliguria 7. Bleeding volume 8. Gastric suction 9. Water balance 10. Ea Value

Contacts

Public ContactYuka Matsuki

University of Fukui Hospital

ymatsuki@u-fukui.ac.jp+81-776-61-8391

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026